在 BIO-RESORT 试验中，使用非常薄的支架聚合物或薄支架持久聚合物药物洗脱支架治疗高出血风险患者。
High Bleeding Risk Patients Treated with Very Thin-Strut Biodegradable Polymer or Thin-Strut Durable Polymer Drug-Eluting Stents in the BIO-RESORT Trial.
机构信息
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Postbus 50.000, 7500, KA, Enschede, the Netherlands.
Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.
出版信息
Cardiovasc Drugs Ther. 2018 Dec;32(6):567-576. doi: 10.1007/s10557-018-6823-9.
PURPOSE
Patients with high bleeding risk (HBR) who undergo percutaneous coronary intervention also have an increased risk of ischemic events and represent an overall high-risk population. The coating of durable polymer drug-eluting stents (DP-DES) may induce inflammation and delay arterial healing, which might be reduced by novel biodegradable polymer DES (BP-DES). We aimed to evaluate the safety and efficacy of treating HBR patients with very thin-strut BP-DES versus thin-strut DP-DES.
METHODS
Participants in BIO-RESORT (NCT01674803), an investigator-initiated multicenter, randomized all-comers trial, were treated with very thin-strut BP-DES (Synergy or Orsiro) or thin-strut DP-DES (Resolute Integrity). For the present analysis, patients were classified following HBR criteria based on previous trials. The primary endpoint was target vessel failure: a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization at 1 year.
RESULTS
Of all 3514 patients, 1009 (28.7%) had HBR. HBR patients were older (p < 0.001) and had more co-morbidities than non-HBR patients (p < 0.001). At 1-year follow-up, HBR patients had significantly higher rates of target vessel failure (6.7 vs. 4.2%, p = 0.003), cardiac death (1.9 vs. 0.4%, p < 0.001), and major bleeding (3.3 vs. 1.5%, p = 0.001). Of all 1009 HBR patients, 673 (66.7%) received BP-DES and 336 (33.3%) had DP-DES. The primary endpoint was met by 43/673 (6.5%) patients treated with BP-DES and 24/336 (7.3%) treated with DP-DES (HR 0.88 [95%CI 0.54-1.46], p = 0.63). There were no significant between-group differences in the most global patient-oriented clinical endpoint (9.7 vs. 10.5%, HR 0.92 [95%CI 0.61-1.39], p = 0.69) and other secondary endpoints.
CONCLUSIONS
At 1-year follow-up, very thin-strut BP-DES showed similar safety and efficacy for treating HBR patients as thin-strut DP-DES.
目的
接受经皮冠状动脉介入治疗的高出血风险（HBR）患者也有发生缺血事件的风险增加，并且代表了一个整体的高危人群。持久聚合物药物洗脱支架（DP-DES）的涂层可能会引起炎症并延迟动脉愈合，而新型可生物降解聚合物 DES（BP-DES）可能会减少这种情况。我们旨在评估治疗 HBR 患者时使用极薄壁 BP-DES 与薄壁 DP-DES 的安全性和疗效。
方法
参与者在 BIO-RESORT（NCT01674803）中，这是一项由研究者发起的多中心、随机、所有患者入组的试验，接受了极薄壁 BP-DES（Synergy 或 Orsiro）或薄壁 DP-DES（Resolute Integrity）治疗。在本次分析中，根据之前的试验，根据 HBR 标准对患者进行分类。主要终点是靶血管失败：包括心源性死亡、靶血管相关心肌梗死或靶血管血运重建的复合终点，随访时间为 1 年。
结果
在所有 3514 例患者中，有 1009 例（28.7%）为 HBR。HBR 患者年龄较大（p<0.001），合并症多于非 HBR 患者（p<0.001）。在 1 年随访时，HBR 患者靶血管失败率显著更高（6.7% vs. 4.2%，p=0.003）、心源性死亡（1.9% vs. 0.4%，p<0.001）和大出血（3.3% vs. 1.5%，p=0.001）。在所有 1009 例 HBR 患者中，673 例（66.7%）接受了 BP-DES 治疗，336 例（33.3%）接受了 DP-DES 治疗。BP-DES 治疗的 673 例患者中有 43 例（6.5%）达到主要终点，DP-DES 治疗的 336 例患者中有 24 例（7.3%）达到主要终点（HR 0.88 [95%CI 0.54-1.46]，p=0.63）。两组之间最全面的以患者为中心的临床终点（9.7% vs. 10.5%，HR 0.92 [95%CI 0.61-1.39]，p=0.69）和其他次要终点均无显著差异。
结论
在 1 年随访时，极薄壁 BP-DES 治疗 HBR 患者的安全性和疗效与薄壁 DP-DES 相似。
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